It’s an exciting time to be involved in the clinical supply chain. With advancements being made in areas such as immuno-oncology, there are new medicines in development bringing new challenges to the supply chain, thereby increasing the demand to bring products to patients quickly and efficiently.
CTA recently spoke to a supply chain expert, who explains how processes within the supply chain need to change in order to keep up with the pace of changing times.
Clinical Trials Arena: What are some of the challenges you face working within the clinical supply chain?
Industry Expert: The biggest challenge we face is the rising number of clinical trials we’re involved in. More than ever, things are moving much faster in the development space. There’s a lot of pressure in developing products quickly in a cost-effective manner, and the nature of those products are changing as well. Historically, in the traditional pharma business model, you’re looking at much bigger individual products and large scale phase III trials.
In oncology, for instance, what you have there is a really active space with smaller launches compared to big blockbusters with very specific patients. A lot of the modern therapies in development are largely targeted towards a particular population, genetic mutations and so forth. What that all means for the clinical trial space is that you’re running many more studies that have to be faster and more adaptable. Sometimes you see more design changes in trials than historically, so speed and agility are becoming much more important.
CTA: How does that impact you in terms of having to deal with a multitude of clinical trials; how do you manage the demand that places on you?
IE: There are various angles to it; one is the interaction with the clinical groups, which is vital. It’s important to understand the trial design, who the contractors are and how likely they are to change. All these factors are vital in setting up the supply chain. You need to be adaptable and flexible in order to act with speed all while not spending too much money.
One of the challenges you’ve got in a complex study, with multiple standards of care, is that it costs a lot of money. As a result, we’re trying to be much smarter in terms of how we forecast the demand.
CTA: How do you ensure that you’re running a trial in a cost-effective manner?
IE: We are starting to implement a new system that helps us visualize the demand more easily across the program. Within the company there are study managers who come up with a design to supply for a particular trial. From there, we look at and aggregate the demand being escalated across a number of studies, as well as from the forecast. Then essentially we have a discussion among project teams about the various options to supply that trial while getting the balance right.
If, for instance, there’s a project that wants to go very fast and wants to have full flexibility, this could potentially be more expensive if you cede material around more sites and more countries. You could look at reducing the number of countries and that in turn would lower supply costs. Ultimately, it’s all about getting the right balance between speed, availability and cost because if the project is different some can be accelerated programs where speed is an overriding factor; others might attempt to do everything cost-efficiently. It’s essential to have a discussion about the project while balancing your supply and demand.
CTA: In your position, what advice would you give fellow professionals who are shipping materials to various sites for different trials?
IE: Set a clear direction for your organization. We set a strategy called the three Vs (increasing velocity, reducing variability and increasing visibility). If you have an organization looking to supply to clinical trials, set a clear, overriding purpose for what you’re trying to achieve and then you can run a variety of improvement initiatives off the back of that. You can improve for instance how you measure your clinical supply performance and that’s all about increasing visibility. You could look at a process for label translation and for IVR, which can reduce the amount of time and increase velocity.